Kornimate/medical-research-clean huggingface dataset:
nasal inhalation of isopropyl alcohol for the treatment of nausea in patients with cancer

Conditions: Malignant Neoplasm

Summary: the goal of this research study is to understand the effect of inhalation approaches in reducing nausea in cancer patients.

in this study, inhalation of a study solution will be compared to inhalation of placebo, both in the form of preparation pads (a small square of material that contains the solution). isopropyl alcohol may be a part of the preparation pads. a placebo is not a drug. it looks like the study solution but is not designed to treat any disease or illness. it is designed to be compared with the study solution to learn if the study solution has any real effect. inhalation of the study solution may help to control your nausea. future patients may benefit from what is learned. there may be no benefits for you in this study. your participation is completely voluntary. before choosing to take part in this study, you should discuss with the study team any concerns you may have, including side effects, potential expenses, and time commitment.

Eligibility criteria:
inclusion criteria: * rate current severity of acute/chronic nausea \>= 4 on nrs (numeric rating scale) * diagnosis of cancer * able to read/write in english * referred to supportive care service as an inpatient or outpatient * rate anxiety as =\< 4 on esas-fs (edmonton symptom assessment scale-financial distress and spiritual pain) * participants must agree to inhale isopropyl alcohol exclusion criteria: * received anti-emetics in the last 30 minutes * received medical procedures (e.g. blood draws) which required exposure of isopropyl alcohol in the last 30 minutes * inability to inhale through nares (including recent upper respiratory infection) * known allergy to isopropyl alcohol * delirium (i.e., score \>= 7 on the memorial delirium assessment scale \[mdas\]) * have never been on anti-emetics during the course of the treatment here (anti-emetic naive)
children born with club feet

Conditions: Clubfoot

Summary: clubfoot is one of the most common birth defects, with a prevalence in europe estimated between 1 and 4.5 for 1000 live birth. it is useful to distinguish the forms of isolated clubfoot, and the forms related to others morphological abnormalities (complex clubfoot). for the complex forms, the clubfoot can be integrated in a syndromic association, be the consequence of a serious harm of the central nervous system, be associate to a genetic musculo-skeletal disease or wether be associated to a karyotype abnormality. in those cases, the prognosis depends more about the associated morphological abnormalities that can be the beginning of a severe disability or incompatible with life or any anomaly of the karyotype that clubfoot itself. in case of several morphological abnormalities, to propose invasive samples with realization of a karyotype and chromosome analysis with cgh array is a consensual attitude. what the investigators should recommended to the parents in case of isolated form is less obvious and the question of antenatal investigations can not be answered clearly in the literature. thus, the management of these patients may vary from one cpdp to another. this study project will make it possible to analyze the management offered to patients whose fetuses have club feet and to study the results of the various examinations carried out in order to adapt the prenatal counselling and to define the best diagnostic strategy to propose to the future parents.


Eligibility criteria:
inclusion criteria: * congenital clubfoot uni or bilateral * have been treated in the reference center " institut saint pierre, plavas-les-flots, france " exclusion criteria: - non confirmed clubfoot after birth

Keywords: ultrasound prenatal diagnosis congenital deformities perinatal outcome
sotagliflozin in heart failure with preserved ejection fraction (hfpef) patients

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: the clinical benefits of the dual sodium-glucose cotransporter (sglt) 1 and 2-inhibition have recently been reported in two clinical trials. the soloist reported the benefits of sotagliflozin in type-2 diabetes mellitus (t2dm) patients hospitalized for worsening of heart failure (hf), while the scored involved t2dm patients with chronic kidney disease (ckd). it is worth noting that not only did the event curves separate within the first week post-treatment, but the effects of sotagliflozin on hf-related outcomes were observed regardless of left ventricular ejection fraction (lvef) values and did not seem to attenuate with increasing lvef as seen with empagliflozin and sacubitril/valsartan. despite the favorable outcomes, the mechanism(s) of action through which sotagliflozin exerts these benefits remains unclear. the present study aims to investigate the potential (non-glucose dependent) "cardio-renal" pleiotropic effects of sotagliflozin in a mechanistic, randomized, double blind, placebo-control trial in hf patients with preserved ejection fraction (hfpef). comparisons between treatment groups will be made using cardiac mri, cpet, 6-mwt and kccq-12.


Eligibility criteria:
inclusion criteria: patients should meet all of the following criteria * ambulatory patients age ≥ 18 years * written informed consent prior to admission to the trial. * no diabetes as confirmed by hba1c \<6.5%, fasting serum glucose \<126 mg/dl, and review of concomitant medications and medical history * diagnosis of heart failure (nyha ii to iii) * lvef \> 50% * on medical therapy for heart failure consistent with prevailing cardiovascular guidelines at a stable dose for ≥4 weeks prior to screening, except for diuretics which must have been stable for ≥2 weeks prior to screening * women of child-bearing potential must agree to use birth control measures with a failure rate of \<1% per year during the treatment period of the study exclusion criteria: * type 1 and type 2 diabetes * acute coronary syndrome (acs) or cardiac surgery within the last week. * pregnant or lactating women, * acute decompensated hf or hospitalized for hf within 1 month from screening visit * glomerular filtration rate (gfr) \< 25 ml/ min/1.73m2, * patients on drugs with potential interaction with sotagliflozin including digoxin, phenytoin, hiv medication and rifampin. * receiving sglt2-i 3-months prior to randomization. * non-mri compatible pm or icd and any other medical or physical condition considered unappropriated by a study physician.
efficacy of a craniosacral therapy protocol in the treatment of infant colic

Conditions: Infant Conditions; Colic, Infantile; Gastro-Intestinal Disorder

Summary: this is a randomised controlled trial that aims to determine the effectiveness of craniosacral therapy for the treatment of infantile colic. manual therapy was applied to a group of young infants diagnosed with colic while a second group did not received any treatment.


Eligibility criteria:
inclusion criteria: * infants diagnosed with colic, * with 0-90 days of age, * who have had 3 hours of unexplainable crying per day for at least 3 days during the week previous to the study. exclusion criteria: * infants diagnosed with any sort of pathological illness, allergies or food intolerance * who have suffered any intracranial hemorrhages or skull fractures.

Keywords: skull osteopathic manipulation infantile colic clinical trial massage infant osteopathic medicine
mangafodipir as an adjunct to percutaneous coronary intervention

Conditions: Myocardial Infarction

Summary: the present feasibility study is designed to find out whether pre-treatment with the compound mangafodipir (pp-099) provides an additional reduction in myocardial infarct size in patients treated with primary percutaneous coronary intervention (pci) during acute myocardial infarction (ami).

mangafodipir, manganese (mn) dipyridoxyl diphosphate (mndpdp) and its lipophile metabolite mn dipyridoxyl diethylene diamide (mnpled), are catalytic antioxidants and iron chelators. in preclinical studies these agents reduce oxidative stress induced injuries related to chemotherapy of cancer and to reperfusion/reoxygenation of ischemic/hypoxic myocardium. accordingly, in an in vivo pig model of ami metabolite mnpled applied at end of ischemia and during reperfusion reduced myocardial infarct size by 55 %. mangafodipir most likely activates salvage pathways and prevents lethal reperfusion injuries. other advantages are that mangafodipir is already approved as a contrast agent for mri of liver, and that the experience for more than a decade reveals a high safety with minor and tolerable side-effects. the present study will include 20 patients treated for their first documented ami. they will after admission to hospital undergo primary pci. reopening of an occluded coronary artery will be preceded by iv. infusion of mangafodipir or placebo in two groups , each consisting of 10 patients. the primary endpoint will be release to plasma of commonly accepted biomarkers of myocardial injury (troponin t and ck-mb) measured at admission and 6 hours after pci. the secondary endpoints include the accumulated release of plasma biomarkers over 48 hours and direct measurement of the final myocardial infarct size at 6-10 weeks after pci.

Eligibility criteria:
inclusion criteria: 1. males 40-80 and females 50-80 years with first severe coronary attack 2. chest pain up to 6 hours. 3. t segment elevation (≥ 0.2 mv in two neighbouring anterior and inferior wall leads. 4. decided for treatment by primary pci. 5. timi grade 0 flow in the occluded lad or rca artery 6. written informed consent. exclusion criteria: 1. previous coronary artery bypass operation. 2. previous ami. 3. chest pain more than 6 hours. 4. angina within 48 hours before admission. 5. cardiac arrest and cardiogenic shock. 6. occlusion of the left main stem, circumflex and right coronary arteries at angiography. 7. known hypersensitivity to mangafodipir (as contrast agent for mri). 8. received mangafodipir ≤ 5 weeks before admission 9. history of prior serious allergic or pseudo-allergic reaction 10. severely reduced liver or renal function 11. any other serious illness or medical condition 12. fertile females 13. phaeochromocytoma

Keywords: mangafodipir primary percutaneous coronary intervention myocardial infarction troponin ck-mb magnetic resonance imaging
facilitating skin-to-skin contact in the postnatal period

Conditions: Breast Feeding; Body Temperature Changes

Summary: this study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by mother-infant dyads. it has three phases including researcher observation, randomised controlled trialing and qualitative midwifery staff perspective. the research will determine the effect a facilitating garment has in comparison to conventionally facilitated skin-to-skin contact, by measuring its effect on the baby's temperature stability, breastfeeding status and weight velocity.

skin-to-skin contact is used as part of a package of kangaroo mother care across the world. this has been demonstrated to reduce neonatal morbidity, mortality, and inpatient stays for low birth weight and preterm infants (charpak and ruiz 2016). this study examines the effect a facilitating garment, the snuby® has on neonatal health outcomes associated with skin-to-skin contact, such as neonatal thermoregulation, breastfeeding status, and self-reported mother-infant bonding. it uses a mixed methods approach to address quantitative and qualitative outcomes including participant's perspectives, and measurable health markers.

Eligibility criteria:
maternal participants inclusion criteria: women, non-binary and transgender participants. aged 16+ years old. vaginal birth, including ventouse, forceps and spontaneous vaginal birth. 28+ weeks pregnant. body mass index of 18 to 30 inclusive. births between 37 and 42 completed weeks of pregnancy. women without any morbidities that will significantly impair their ability to independently parent their baby. women planning to give birth on the labour ward, co-located birth centre, standalone birth centre or at home. exclusion criteria: caesarean section births. high dependency unit patients. illiterate in english. multiple pregnancies e.g. twins. registered child protection concerns. substance misusing women. body mass index of less than 18 at booking appointment. body mass index of more than 30 at booking appointment. aged under 16 years old. neonatal participants inclusion criteria: born 37 to 42 completed weeks gestation. birth weight between 2500g and 4000g . weight at six weeks of age less than 6000g. neonates requiring blood glucose prefeed monitoring. from birth to six weeks of age. exclusion criteria: preterm neonates (less than 37 weeks gestation). requirement for special or intensive neonatal care. receiving phototherapy. receiving intravenous antibiotics. falling growth velocity of more than 2 centiles. aged over 6 weeks old. midwifery staff participants inclusion criteria: working at the national health service trust hosting the research. working through the hospital bank. registered midwife through the nursing and midwifery council. working on band 5, 6 or 7. working within the hospital setting. exclusion criteria: midwifery staff working in the community without rotating to the hospital wards.

Keywords: skin-to-skin kangaroo care kangaroo mother care
efficacy and safety of ql1206 in the treatment of postmenopausal osteoporosis with high fracture risk

Conditions: Postmenopausal Osteoporosis

Summary: a randomized, double-blind, two-group parallel, placebo-controlled clinical phase iii trial to compare the efficacy and safety of ql1206 and placebo in postmenopausal women with osteoporosis at high risk of fracture

this is a randomized, double-blind, two-group parallel, placebo-controlled clinical phase iii trial. the primary objective is to evaluate the effect of ql1206 treatment compared with placebo in chinese postmenopausal women with osteoporosis at high risk of fracture. the secondary objective is to evaluate the clinical safety, immunogenicity and pharmacokinetic (pk) characteristics of ql1206 in women with osteoporosis at high risk of postmenopausal fracture the exploratory purpose is to evaluate the effect of ada on the characteristics of ql1206 pk and the relationship between ql1206 exposure and pharmacodynamic endpoints, efficacy and adverse events subjects would sequentially enrolled according to the protocol in one of two cohorts.subjects would receive a single 60mg of ql1206 or placebo every 6 month for1 year(twice for one, subcutaneous injection) ,meanwhile taking 500 mg of calcium and 1000iu of vitamin d daily

Eligibility criteria:
inclusion criteria: 1. subject is willing to provide written informed consent. 2. ambulatory woman between the age of 50 and 85 years, inclusive. 3. the subject has a bmd absolute value consistent with a t-score\ -4.0 at either the lumbar spine or total hip 4. all subjects must have at least one of following additional the risk factors:history of fracture（after 40 years）,parental history of hip fracture, low body mass index (bmi≤19kg/m\^2), elderly (age≥65year)，current smoker 5. postmenopausal defined as \>2 years postmenopausal, which can be \>2 years of spontaneous amenorrhea or \>2 years post surgical bilateral oophorectomy. exclusion criteria: 1. bone/metabolic disease:a. any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,which may interfere with the interpretation of the findings. b. paget's disease c. cushing's disease d. hyperprolactinemia 2. current hyperparathyroidism or hypoparathyroidism by medical record 3. thyroid condition: hyperthyroidism or hypothyroidism. 4. rheumatoid arthritis -
intravitreal bevacizumab for idiopathic macular telangiectasia

Conditions: Retina; Telangiectasis

Summary: idiopathic macular telangiectasia is characterized by incompetent and dilated retinal capillaries in the foveolar region of unknown cause for retinal telangiectasia. in idiopathic macular telangiectasia, proliferative changes occur in the deep retinal capillary network, leading to intraretinal neovascularization that, unlike in age-related macular degeneration, seems to be retinal rather than choroidal in origin. before the hemorrhagic and fibrotic state, these vessels may lead to exudation and decrease in the visual acuity. long-term visual prognosis in patients with this complication may be poor and treatment with laser photocoagulation is unproven. although newly reported treatment, by photodynamic therapy for neovascular membrane associated with idiopathic macular telangiectasia, may show vision and angiographic stability in a few cases, the improvement may be transient. vegf has been implicated as the major angiogenic stimulus responsible for neovascularization in amd, ensuing specific anti-vegf treatment in these cases. the purpose of the study is to evaluate intravitreal injection of bevacizumab (1.25mg/0.05ml) in the treatment of idiopathic macular telangiectasia.


Eligibility criteria:
inclusion criteria: * patients with idiopathic macular telangiectasia * patient consent exclusion criteria: * heart attack or cerebrovascular attack * previous treatment for others retinopathy * media opacities that preclude visualization of the fundus * inability to understands the implications of the protocol

Keywords: fovea centralis/pathology fundus oculi retinal neovascularization telangiectasis/diagnosis tomography, optical coherence vitreous body/drug effects
myofascial induction and eccentric exercises in volleyball players

Conditions: Myofascial Pain

Summary: introduction. myofascial therapy aims to improve fascial restrictions through the application of mechanical stimuli. the eccentric exercises involve the recruitment of fast fibers and help increase muscle volume. aim. compare the effectiveness of myofascial induction intervention in the improvement of the range of motion of glenohumeral rotation and the pain perception, with respect to the use of eccentric exercises in volleyball players from 18 to 35 years of age. study design. multicenter and single-blind randomized clinical study with follow-up period. methods. a random assignment of the 40 subjects recruited to the different study groups will be carried out: experimental (myofascial induction technique and eccentric exercises) and control (eccentric exercises). the intervention will last 4 weeks, with a weekly session of 17 and 7 minutes (in the experimental and control group, respectively). the dependent variables and measurement instruments will be: internal and external shoulder rotation (goniometry) and pain perception (visual analog scale). the kolmogorov-smirnov test will calculate the distribution of the sample, using parametric tests (t-student to calculate the difference of means between the evaluations in each group and anova of repeated measures to calculate the intra- and intersubject effect) in case of normal. expected results. to improve the range of motion of glenohumeral joint global rotation and of the perception of pain of the subject.


Eligibility criteria:
inclusion criteria: * volleyball players * both gender * age range of 18 to 35 years * compete in a federated team in the community of madrid. exclusion criteria: * have an injury to the osteoarticular complex of the shoulder at the time of the study or the previous 6 months * who are receiving a physiotherapy intervention at the time of the study or receiving analgesic drugs * not signed the informed consent document.

Keywords: volleyball range of motion myofascial eccentric pain
foot assessment in people with diabetes: a quantitative diagnostic approach

Conditions: Diabetes; Diabetic Foot; Diabetes Complications; Diabetes; Neuropathic (Manifestation)

Summary: this observational cohort study aims to develop a novel risk stratification system implementing biomechanics to aid in the prevention of diabetic foot ulcers.

the purpose of this research observational cohort study is to investigate the applicability of using biomechanical assessment in predicting the ulceration incidence in patients with diabetic neuropathic feet. the proposed study will lead to the development of further stratification of high-risk patients into subcategories indicating the vulnerability of tissue to mechanical trauma, which deemed to be the leading cause of ulceration in people with diabetic neuropathy. as it stands, the current systems used to evaluate the risk of diabetic foot rely on global parameters such as duration of diabetes and glycated hemoglobin to predict the likelihood and risk of diabetic foot ulceration. as ulceration happens as a result of repeat mechanical trauma to the foot that doesn't heal quickly enough due to other complications of diabetes, it is important to include mechanical measurements in predicting the ulceration incident in diabetic neuropathic patients. despite this, the currently used risk stratification systems do not include biomechanics so by introducing biomechanics it will potentially be possible to predict the ulceration risk by using more local measurements. the primary objective is to employ the measures of neuropathy, micro/macro-perfusion, and biomechanics of the foot mainly tissue stiffness and plantar pressure to determine the vulnerability of foot to mechanical trauma and ulceration. from the data collected it is proposed that a prognostic risk stratification system will be developed based on the range of parameters collected to identify those that are at highest risk of ulceration incident. those that are classed as high risk are to be sub-stratified to increase the accuracy of the system in predicting ulceration. this will allow a patient-specific approach to be taken in the prevention of ulcers by providing adequate information to predict ulceration incident. this then can be used to determine the likelihood of an ulcer forming. furthermore, the possibility of identifying the ulceration site will be investigated.

Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetes * over 18 * english speaking * ability to walk unaided over 5m * diabetic neuropathy as defined by a 10g monofilament test exclusion criteria: * lower limb surgery (amputation) * active ulcers * history of neurological disorders (apart from neuropathy) * orthopaedic problems * systemic disease affecting mobility or leading to chronic inflammation of any lower limb joint. * visual impairment leading to difficulties in walking * charcot foot * unable to walk unaided for 5m

Keywords: diabetes diabetic foot biomechanics stratification diabetes complications diabetes; neuropathic (manifestation) risk factors prospective studies